U.S. Senate Votes to Overhaul FDA
In what's being described as the "most comprehensive drug safety overhaul in more than a decade," the U.S. Senate voted overwhelmingly Wednesday to give the U.S. Food and Drug Administration sweeping new powers to protect consumers from dangerous medicines.
The vote, 93 to 1, would give the FDA broad authority to oversee drug safety, order changes in drug labels, and limit the use and distribution of medicines found to pose serious health risks to consumers, The New York Times reported.
The FDA's traditional role has been to ensure the safety of drugs and medical devices prior to authorizing their use. The new bill, which is likely to be approved by the House of Representatives and signed by President Bush, calls for a fundamental change in the philosophy and operations of the agency, the Times said. The FDA would now be charged with monitoring and overseeing the entire life cycle of a drug -- from the pre-approval review through to patients' experiences with a medicine, the newspaper said.
The FDA's image has taken a beating in recent years, starting with the 2004 removal from the market of the arthritis drug Vioxx, which was eventually found to increase the likelihood of heart attack and stroke. Senators said the new bill was an effort to restore Americans' confidence in the FDA's ability to protect consumers. The bill would also meet many recommendations from the National Academy of Sciences, the newspaper said.
"This legislation will make a major difference for families in America, ensuring the safety of our prescription drug system," said Sen. Edward M. Kennedy, (D-Mass.), the chief sponsor of the bill. "We will also have safer food for families and for pets," Kennedy added, referring to the series of high-profile food contamination problems that first surfaced last fall.
Sen. Michael B. Enzi, (R-Wyoming), said the bill was the "most comprehensive drug safety overhaul in more than a decade."
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Report Cites U.S. Health-Care Disparities
Despite some improvements, differences in the quality of health care provided to American women and men and different racial and ethnic groups persist, says the latest News and Numbers from the federal Agency for Healthcare Research and Quality.
Among the improvements:
- In 2004, nearly as many female Medicare patients (85 percent) as male Medicare patients (86 percent) received recommended care in a hospital after a heart attack. In 2002, the rates were 79 percent of women and 81 percent of men.
- Women were more likely than men to have a usual source of ongoing health care in 2004 -- 90 percent compared to 83 percent. A usual source of care is associated with lower costs and improved health results.
But the bad news is that more women were more likely than men (56 vs. 38 per 100,000 people) to be hospitalized for high blood pressure in 2003. Hospitalization for high blood pressure can usually be prevented if a patient has good quality primary care.
Among other examples of gender or racial/ethnic disparities:
- In 2003, women age 50 and older were less likely than men (50 percent vs. 54 percent) to receive recommended colorectal cancer screening.
- Colorectal cancer screening rates for white women were 50 percent, compared with 44 percent for black women and 38 percent for Hispanic women.
- 86 percent of white women start prenatal care in the first three months of pregnancy, compared with 78 percent of Hispanic women, 76 percent of black women, and 71 percent of American Indian-Alaska Native women.
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Scientists to Catalog 1.8 Million Known Species
All the world's 1.8 million known species will be catalogued in a massive new $12.5 million Web project called the "Encyclopedia of Life," scientists announced this week.
The goal of the project is to create separate Web pages on every known species within a decade, the Washington Post reported. Entries will include written sections, photographs, video and sound recordings, and locator maps when possible.
The effort is a collaboration of Chicago's Field Museum, the Smithsonian Institution, Harvard University, the Marine Biological Laboratory at Woods Hole, Mass., the Missouri Botanical Garden and the Biodiversity Heritage Library.
To date, humans have catalogued only about 10 percent of the world's species and much of that information is fragmented, Harvard biologist Edward O. Wilson told the Post.
Wilson, who helped initiate the Encyclopedia of Life, said the undertaking will create a pool of knowledge similar to the Human Genome Project.
"In a relatively short period of time, we'll be able to fill up everything that is known on a given species," Wilson said. "It's something that's invaluable, and its time has come."
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Doctors Paid Millions to Prescribe Anemia Drugs
U.S. doctors are being paid millions of dollars a year by drug makers Amgen and Johnson & Johnson in return for prescribing anemia medicines to patients that may be unsafe at commonly used doses, The New York Times reported Wednesday.
According to industry analysts, the payments to doctors for prescribing the drugs -- Aransep and Epogen from Amgen; and Procrit from Johnson & Johnson -- may amount to hundreds of millions of dollars a year. The drugs are given to treat anemia caused by kidney disease or cancer chemotherapy.
Neither Amgen or Johnson & Johnson have revealed the total amount of the payments, which are structured in a way that make them legal under federal law, The Times reported.
Both patients and doctors would benefit from full disclosure about the payments and the profits doctors make from the payments, said Dr. Len Lichtenfeld, the American Cancer Society's deputy chief medical officer.
On Tuesday, the Food and Drug Administration released a report suggesting that it may be necessary to limit the use of these anemia drugs in cancer patients. The report said research indicates that there's no evidence that the drugs improve quality of life or extend the lives of cancer patients. It also said that a number of studies suggest that high doses of the drugs may shorten patients' lives, The Times reported.
An FDA panel is scheduled to meet Thursday to discuss whether the drugs are overused. In March, the FDA ordered stronger warnings on the drugs' labels.
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Chinese Company Linked to Cough Medicine Deaths Not Licensed
The Chinese company linked to toxic cough medicine that killed at least 100 people in Panama was not licensed to be in the pharmaceutical business, say Chinese officials.
The cough medicine was tainted with a poisonous industrial solvent called diethylene glycol, that was falsely identified as glycerin, a sweet-tasting syrup widely used in medicine, The New York Times reported.
On Tuesday, a Chinese Foreign Ministry spokeswoman said the neither the chemical company that made the toxic syrup -- the Taixing Glycerine Factory -- nor the state-owned trading firm that exported it -- CNSC Fortune Way -- were under the regulatory supervision of China's State Food and Drug Administration.
The Chinese agency conducted an investigation in response to a request from the U.S. Food and Drug Administration, The Times reported.
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Cracker Barrel Pulls Hamburgers After Woman Injured
The Cracker Barrel Old Country Store restaurant chain has removed hundreds of hamburgers from its stores after a customer in Myrtle Beach, S.C. said she cut her mouth on a piece of metal in a patty, the Associated Press reported.
The restaurant chain removed more than 300 burgers made at or around the same time as the one involved in the incident. The burgers, which are frozen and pre-formed, were made by Cargill Meat Solutions of Wichita, Kan.
An investigation is being conducted by Cracker Barrel, the burger supplier, and police, the AP reported.
The 56-year-old female customer went to a hospital Saturday night after she began bleeding from the mouth and said something was stuck in her throat after eating part of a burger.
A police report said the restaurant manager found a piece of razor blade in the middle of the woman's half-eaten burger patty. Another piece of razor blade was later found in the patty.
The woman did not require stitches. Her husband said she was waiting to hear whether she need more medical tests, the AP reported.
Cracker Barrel has 557 restaurants in 41 states.
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FDA Approves Respirators for Use in Flu Pandemic
Two filtering facepiece respirators have been approved by the U.S. Food and Drug Administration for use in an influenza pandemic and other public health emergencies. They're the first to receive such approval.
The respirators, which help reduce a user's exposure to airborne germs, are available without a prescription. They're made by St. Paul, Minn.-based 3M Company.
The 3M Respirator 8612F and 8670F fit tightly over the nose and mouth and are made of fibrous material designed to filter out at least 95 percent of very small airborne particles.
"While the exact nature and concentration of the biological agent or germ may not be known in a public health medical emergency, we believe that minimizing exposure will help reduce risk," Dr. Daniel Shultz, director of the FDA's Center for Devices and Radiological Health, said in a prepared statement.
"These respirators are only one part of a combination of approaches that can be used to help reduce the spread of infection between individuals during such events," Schultz said.
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